- diclofenac sodium
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 49452/0001.
Package leaflet: Information for the user
Solacutan® 3% gel
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Solacutan gel is and what it is used for
2. What you need to know before you use Solacutan gel
3. How to use Solacutan gel
4. Possible side effects
5. How to store Solacutan gel
6. Contents of the pack and other information
1. WHAT SOLACUTAN GEL IS AND WHAT IT IS USED FOR
Solacutan gel is a non-steroidal antiinflammatory dermatological gel. Solacutan gel is applied to the skin to treat a skin problem known as actinic or solar keratosis that is caused by long-term extensive sun exposure.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOLACUTAN GEL
Do not use Solacutan gel
Warnings and precautions
Talk to your doctor or pharmacist before using Solacutan gel.
Children and adolescents
Dosage recommendations and indications for the use of Solacutan have not been established for use in children and adolescents.
Other medicines and Solacutan gel
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, ask your doctor for advice before using Solacutan gel. Solacutan gel should be used with caution during the first six months of pregnancy but it must not be used during the last three months of pregnancy.
Consult your doctor if you are breast-feeding. Solacutan gel can be used with caution whilst breast-feeding but it must not be used on the breasts.
If you are pregnant, planning to have a baby, or breast-feeding, and your doctor considers treatment appropriate, Solacutan gel must not be applied to an area of the skin larger than a third of your body and must not be used for longer than three weeks.
Ask your doctor or pharmacist for advice before taking/using any medicine.
Driving and using machines
No specific precautions are necessary.
Solacutan gel contains benzyl alcohol
This medicine contains 15 mg benzyl alcohol per each gram of gel.
Benzyl alcohol may cause allergic reactions and mild local irritation.
3. HOW TO USE SOLACUTAN GEL
If you use more Solacutan gel than you should
Remove excess gel by washing with water.
If you forget to use Solacutan gel
Continue to apply as directed but do not apply twice as much to make up for the missed application.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following side effects, stop using Solacutan gel and contact your doctor as soon as possible:
Skin rash (nettle rash), breathing problems (wheezing); swelling of the face; runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to Solacutan gel.
If any of the following common side effects are severe or last for more than a few days, you should stop using Solacutan gel and contact your doctor: itching, skin rash, skin redness, inflammation, contact dermatitis, pain and blistering.
Other common side effects:
(may affect up to 1 in 10 people)
Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful sensation when the skin is touched, pins and needles, muscle stiffness, inflammation of the skin, eczema, dry skin, swelling, skin rash (including scaling or blistering), sagging of the skin and skin ulcer.
Uncommon side effects:
(may affect up to 1 in 100 people)
Eye pain, weeping/dry eyes, abdominal pain, diarrhoea, feeling sick, hair loss, facial swelling, excessive bleeding or oily skin, a measles-like skin rash.
Rare side effects:
(may affect up to 1 in 1,000 people)
Skin inflammation with large blisters
Very rare side effects:
(may affect up to 1 in 10,000 people)
Bleeding from your stomach, kidney problems, breathing difficulties (asthma), all types of hypersensitivity reactions (including nettle rash, rapid swelling of the skin and mucous membranes), infected skin rash, skin sensitivity to sunlight.
Temporary hair discolouration at the application site has been reported. This is usually reversed after stopping treatment.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SOLACUTAN GEL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Shelf life once opened
Once the tube is opened, Solacutan gel has a shelf life of 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Solacutan gel contains
The active substance is:
1 g gel contains 30 mg diclofenac sodium.
The other ingredients are:
sodium hyaluronate; macrogol 400; benzyl alcohol; purified water
What Solacutan gel looks like and contents of the pack
Solacutan gel is a clear, transparent, colourless to yellowish gel and is supplied in aluminium tubes containing 10 g, 25 g, 26 g, 30 g, 50 g, 60 g, or 90 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in August 2019.
Marco Polo House, 3 - 5 Lansdowne Road, Croydon, CR0 2BX
+44 (0)2038 707 503
+44 (0)2038 707 503
+44 (0)2038 707 503
+44 (0)2038 707 503